Selected tags: Significant New Use Rule (SNUR)

Flame retardants impair normal brain development: Even more evidence, still no action

Jennifer McPartland, Ph.D., is a Health Scientist.

Today a new study was published linking fetal exposure to certain flame retardants called polybrominated diphenyl ethers (PBDEs) with cognitive and behavioral effects that develop later in childhood.  While the specific findings in this study are new, the link between these types of neurodevelopmental effects and exposure to PBDEs is not. 

Numerous scientific studies and governmental bodies across the globe have flagged the health effects of PBDEs.  At the same time, current proposals by the Environmental Protection Agency (EPA) to better understand the hazards and sources of certain PBDEs remain in limbo.  Read on to learn more about today’s new study on PBDEs and the stalling of EPA initiatives to help protect us from exposure to them.  Read More »

Posted in Health Policy, Health Science, Regulation | Also tagged , , , | Comments closed

Maybe not surprising, but still upsetting: New report highlights role of election-year politics in OIRA delays

Rachel Shaffer is a research assistant.

Earlier this month, the Administrative Conference of the United States (ACUS) completed an investigation into the Office of Information and Regulatory Affairs’ (OIRA) long delays in reviewing proposed and final rules and to offer recommendations for improving the efficiency and transparency of OIRA’s review process. The final report – which was featured in a front page story in the Washington Post – echoes and expands upon concerns we discussed in a previous blog post and a joint letter sent to Senator Blumenthal’s office earlier this year.

ACUS documents that the average time for OIRA reviews has significantly increased in recent years. From 1994-2011, the average review time was 50 days. However, in 2012, the average review time rose to 79 days. And in the first part of 2013, the average review time rose further to 140 days

The reason for these growing delays?  Read More »

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This SNUR is not a SNORE!

Jennifer McPartland, Ph.D., is a Health Scientist.

Yesterday EPA finalized a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) that requires manufacturers and importers of certain perfluorinated chemicals to notify EPA at least 90 days before commencing any “significant new use” of these chemicals.  (See below for what EPA has designated to be a “significant new use.”)

These notifications afford EPA an opportunity to evaluate the designated new uses before they start and address any risks the new uses may pose.  Read on to learn more about some novel aspects of this final rule, including the scope of what EPA has designated as significant new uses of these chemicals.  Read More »

Posted in EPA, Health Policy, Regulation | Also tagged , | Comments closed

NGOs ask Senators to investigate chronic delays in OMB’s review of TSCA regulatory actions

Rachel Shaffer is a research assistant.  Richard Denison, Ph.D., is a Senior Scientist.

Last Friday afternoon, we received the discouraging news that EPA has withdrawn two draft rules it had developed under its Toxic Substances Control Act (TSCA) authority.  As discussed in our earlier blog post, these proposed rules had been kept in limbo by the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), for 1,213 and 619 days, respectively – far longer than the 90-day limit for such reviews set by Executive Order 12866.

Unfortunately, these delays are anything but unique.  OIRA’s reviews of draft rules and other actions now routinely exceed by large margins their mandated deadlines.  Our examination of EPA’s TSCA regulatory agenda over the past several years reveals just how extensive OIRA’s “rulemaking purgatory” has become.  

Since 2009, a total of 33 TSCA-related notices or proposed or final regulatory actions have been submitted to OIRA:

  • Eighteen submissions were proposed or final rules subject to a 90-calendar-day deadline.  Reviews of only six of these rules were completed within this deadline; on average, they have been held at OIRA for over 300 days.
  • The other 15 were advance notices of proposed rulemakings or other notices subject to a 10-working-day deadline.  Of these notices, only one was completed within this deadline; on average, they were kept under review by OIRA for over 70 working days.

Today, EDF, Earthjustice, Union of Concerned Scientists, and League of Conservation Voters sent a letter documenting these delays and expressing our serious concerns to Senator Richard Blumenthal (D-CT) and Senator Orrin Hatch (R-UT), Chairman and Ranking Member, respectively, of the Senate Judiciary Committee’s Subcommittee on Oversight, Federal Rights, and Agency Action.  Our letter emphasized that such delays both prevent the public from providing input in the rulemaking process and limit EPA’s already constrained ability to obtain and share basic safety information on chemicals under TSCA.

Our letter was sent in response to an August 1, 2013, hearing held by that subcommittee, titled Justice Delayed: The Human Cost of Regulatory Paralysis, which began a much-needed discussion of the real-world impact of OIRA’s protracted review of proposed regulations.  We urged a further investigation into the causes and consequences of this too-hidden obstruction of the long-established rulemaking process. 

You can read our letter here, and stay tuned for updates in the coming months.

 

Posted in Health Policy, Regulation | Also tagged , | Comments closed

Doing its best under a flawed law: 35 groups file comments supporting EPA efforts to reduce exposure to toxic flame retardants

Jennifer McPartland, Ph.D., is a Health Scientist. Richard Denison, Ph.D., is a Senior Scientist.

Today Environmental Defense Fund and Earthjustice, joined by 33 other health and environmental groups, filed comments that urge the U.S. Environmental Protection Agency (EPA) to swiftly move forward with two proposed actions to regulate a group of toxic flame retardants called PBDEs (polybrominated diphenyl ethers). 

The first proposed rule would require anyone intending to begin production, processing or import of any PBDE, or a product containing one, to notify EPA before doing so.  This would give the agency an opportunity to evaluate the risks of the proposed activity and if necessary take action to restrict or prohibit it.  The second proposed rule would require anyone who continues after 2013 to produce, process or import any PBDE, or a product containing one, to conduct extensive tests needed to allow EPA to determine the risks posed by those ongoing activities.   Read More »

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No orphan left behind: Health and environmental NGOs support EPA’s proposed paired rules to address high production volume "orphan" chemicals

Richard Denison, Ph.D., is a Senior Scientist.  Allison Tracy is a Chemicals Policy Fellow.

Environmental Defense Fund today submitted comments along with 15 other health, environmental justice and state and national environmental organizations, in support of EPA’s proposed rule to address the final batch of 45 “orphan” chemicals that were never sponsored under the agency’s earlier High Production Volume (HPV) Challenge Program.

An earlier post to this blog highlighted and applauded the novel, innovative and efficient approach EPA has proposed, which actually entails the coupling of two rules:

(1) a test rule for 23 of these HPV chemicals for which EPA can make the requisite exposure findings to require testing, combined with:

(2) a Significant New Use Rule (SNUR) for the other 22 HPV chemicals for which EPA cannot presently make such findings, which requires companies to notify EPA if their production or use of those chemicals changes so as to increase the potential for exposure and then warrant testing.

The comments we filed today reiterate our strong support for this approach – and propose that the same approach be extended to several additional batches of HPV chemicals that still lack a basic set of hazard data.

Read More »

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EPA proposes yet another TSCA workaround: Creative, yes, but why not just give it the authority it needs?

Richard Denison, Ph.D., is a Senior Scientist.

One thing I’ve learned in observing EPA try to operate under the Toxic Substances Control Act (TSCA) over the years is that – faced with limited authority and significant evidentiary and resource burdens – the Agency often has to resort to a workaround to get something it needs to do done.

Can’t ban a nasty chemical?  Wait until it’s voluntarily withdrawn and then pounce on it with a Significant New Use Rule (SNUR) to try to wedge the door closed.  Witness PFOS and penta and octaBDE.  (Under TSCA, without a SNUR in place on a chemical, a new producer or importer could start up without even letting EPA know; where EPA has issued a SNUR for a chemical, advance notification is required and EPA least has a chance to weigh in before production or import proceeds.)

Can’t require an up-front minimum data set for new chemicals?  Recommend to companies that for certain chemicals they submit such a data set along with the pre-manufacturing notice (PMN) they’re required to file, or risk having EPA extend the review of their new chemical or negotiate with them to do the testing.  EPA has made such “recommendations” for those relatively few new chemicals where the company “anticipates” at the outset producing it in large amounts in the first three years or where significant release or exposure is projected. 

The latest such workaround?  EPA’s simultaneous issuance of a proposed test rule and a proposed SNUR for a batch of high production volume (HPV) “orphan” chemicals that no company agreed to sponsor under the Agency’s voluntary HPV Challenge Program.

Necessity is the mother of invention, they say, and these creative new proposals are a case in point.  But, my oh my, there’s gotta be a better way…. Read More »

Posted in EPA, Health Policy, Regulation | Also tagged , , , | 1 Response, comments now closed

EPA moves chemical reporting into the 21st century – though we’ll have to wait until mid-decade to actually get there

Richard Denison, Ph.D., is a Senior Scientist.  Allison Tracy is a Chemicals Policy Fellow.

A major initiative of EPA’s toxics office finally made it across the finish line yesterday when EPA posted a pre-publication copy of the final rule upgrading its chemical reporting system under the Toxic Substances Control Act (TSCA).  The process took over 16 months just to get from the draft of the proposed rule to yesterday’s final rule, with EPA having to endure not one but two nearly six-month regulatory reviews by the Office of Management and Budget.

The wait was largely worth it:  EPA’s new program – renamed the Chemical Data Reporting (CDR) rule – significantly advances chemical production and use reporting relative to its predecessor, the more arcane-sounding Inventory Update Reporting (IUR) rule.  Most, though not all, of the critical elements EPA proposed last year made it through to the final rule.  The catch is we’ll have to wait until 2016 for the program to reach its full potential.  Read More »

Posted in EPA, Health Policy, Regulation | Also tagged , , | 1 Response, comments now closed

Funny name, serious concern: EPA proposes Significant New Use Rule for 14 glymes

Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.

EPA today proposed a Significant New Use Rule (SNUR) that, once finalized, would mandate that companies notify EPA prior to engaging in any “significant new use” of any of the 14 chemicals EPA has identified collectively as glymes.  Among other concerns, EPA has identified their use in various consumer products and their potential to cause reproductive and developmental toxicity.  For most of the glymes, the significant new use would be any use in a consumer product beyond those that are already ongoing.  For two of these chemicals, the significant new use would be any use.

This proposed SNUR, which was mired at the Office of Management and Budget (OMB) for more than six months, is now out for a 60-day public comment period.  A SNUR is essentially the only means available to EPA under the Toxic Substances Control Act (TSCA) by which it can try to limit the use of an existing chemical of concern.  It is far from a perfect means of doing so.

Nonetheless, within its limited authority under TSCA, today’s step by EPA brings at least some degree of scrutiny over a quite nasty group of chemicals.  Read More »

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Waiting for Godot: 405 days and counting at OMB on EPA’s modest proposal to identify chemicals of concern under TSCA

Richard Denison, Ph.D., is a Senior Scientist.

Yesterday, three legal scholars from the Center for Progressive Reform (CPR) sent a letter to Cass Sunstein, Administrator of the Office of Information and Regulatory Affairs (OIRA) in the White House Office of Management and Budget (OMB).  That letter rebutted on legal grounds the call made by the U.S. Chamber of Commerce in its own letter to Mr. Sunstein for OMB to force EPA to withdraw its proposal to use its authority under the Toxic Substances Control Act (TSCA) to list chemicals of concern.

EPA’s proposal, which entails use of its clear authority under Section 5(b)(4) of TSCA, has been stalled at OIRA for 405 days as of today, with OIRA refusing even to allow the proposal out for public comment.  I wrote an extensive blog post earlier about all of the reasons why EPA’s proposal is legally sound and makes good market sense.  That post – titled “Why is OMB blocking EPA from using even its limited authority under TSCA?” – went up way back in December, and there’s been no movement on the proposal since then.

CPR’s letter rebuts the Chamber’s claims, noting that it plain and simply “Gets the Law Wrong.”  EDF, too, has developed a legal analysis of EPA’s authority under TSCA to identify and list chemicals of concern, which is fully consistent with CPR’s analysis but goes further to address a few other legal aspects of the issue.  That’s why I’ve decided to post it here.

I’ll leave you to read our memo for the details, but provide its conclusion here as a teaser:

“EPA has clear authority under Section 5(b)(4) to list chemicals of concern and is not required to establish criteria in advance of the issuance of a proposed rule listing specific chemicals.  EPA’s authority also extends to the listing of categories of chemicals.  The legal threshold for action under Section 5(b)(4) should be interpreted as identical to that in Section 4(a), which requires only a “more than theoretical” basis for concluding that a chemical “may present” an unreasonable risk.  Even if Section 5(b)(4) is interpreted to mean something different from that in Section 4(a), it should be interpreted to be far less restrictive than the standard in Section 6.  In addition, Section 5(b)(4) does not require consideration of economic impact in the decision to list a chemical.  Finally, the statute is clear that listing of a chemical in a proposed rule under Section 5(b)(4) triggers export notification under Section 12, and may require the issuance of a SNUR [Significant New Use Rule] with respect to significant new uses of the chemical.”

It’s a sad state of affairs when even this modest step proposed by EPA to use its clear authority under TSCA is not even being allowed by OMB to see the light of day and benefit from public review and comment.

Samuel Beckett’s play, which I borrowed for the title of this post, is described as an absurdist play.  That pretty much sums up the endless review by OMB of EPA’s modest proposal.

Posted in EPA, Health Policy, Regulation | Also tagged , | Comments closed
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